Ignite Creation Date:
2025-12-24 @ 5:06 PM
Ignite Modification Date:
2025-12-28 @ 2:58 PM
Study NCT ID:
NCT04076150
Status:
RECRUITING
Last Update Posted:
2022-09-21
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Performance Study of the Optimum Transcatheter Aortic Valve
Sponsor:
Thubrikar Aortic Valve, Inc.
Organization:
Study Overview
Official Title:
A First-in-Human Study to Access Feasibility and Safety of the Optimum Aortic Valve Implant
Status:
RECRUITING
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The TAVI (Thubrikar Aortic Valve, Inc.) -1 Study: Safety and Performance Study of the Optimum Transcatheter Aortic Valve- First-in-human study to assess feasibility and safety of the Optimum Aortic Valve Implant
Detailed Description:
The purpose of the study is to assess the safety and performance of the Optimum TAV (Transcatheter Aortic Valve) in patients with symptomatic, severe aortic stenosis who are deemed high-risk for SAVR (Surgical Aortic Valve Replacement) or have contraindications or deemed inoperable for SAVR.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: